A Trial to Evaluate Laparoscopic Versus Open Surgery for Colorectal Cancer

Haruhiko Fukuda

Status and phase: Completed; Phase 3

Conditions: Colorectal Cancer

Treatments: Procedure: laparoscopic colectomy; Procedure: open colectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT00147134

JCOG0404

C000000105

Details and patient eligibility

About

The purpose of this study is to evaluate oncological outcome of patients for T3 and T4 colorectal cancer undergoing laparoscopic versus open surgery.

Full description

The benefits of laparoscopic surgery (LAP) in comparison to open surgery (OPEN) have been suggested with respect to decreased morbidity, decreased pain, faster recovery, and shorter hospital stay.1-4 However, the long-term survival of LAP for colorectal cancer is still unclear, especially for advanced colorectal cancer requiring extended lymphadenectomy. Thus, the investigators designed a study which investigates whether LAP is suitable for advanced colorectal cancer with respect to survival and post-operative morbidity.

Enrollment: 1,050 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Histologically proven colorectal carcinoma
2. Tumor located in the cecum, ascending colon, sigmoid colon, or rectosigmoid colon
3. T3 or deeper lesion without involvement of other organs
4. Without multiple lesion other than carcinoma in situ
5. Cancer classified as N0-2 and M0, according to the TNM classification system
6. Tumor size < 8 cm
7. No bowel obstruction
8. Age 20 < and > 75 years
9. Sufficient organ function
10. No history of gastrointestinal surgery
11. No history of chemotherapy or radiotherapy
12. Provided written informed consent

Exclusion criteria

1. Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ
2. Severe pulmonary emphysema, interstitial pneumonitis, or ischemic heart disease
3. Pregnant or lactating women
4. Severe mental disease
5. Continuous systemic steroid therapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,050 participants in 2 patient groups

1

Active Comparator group

Description:

Procedure/Surgery: open colectomy

Treatment:

Procedure: open colectomy

2

Experimental group

Description:

Procedure/Surgery: laparoscopic colectomy

Treatment:

Procedure: laparoscopic colectomy